A Clinical Comparison of Two Multifocal Toric Soft Contact Lenses

NCT ID: NCT06438601

Last Updated: 2025-08-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-24
• Study Completion Date: 2024-08-15

Brief Summary

This study aims to compare the short-term clinical performance of the two study contact lenses.

Detailed Description

The aim of this study is to evaluate the short-term clinical performance of two multifocal toric soft contact lenses after 15 minutes of daily wear each.

Conditions

Astigmatism; Presbyopia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Lens A (omafilcon A)

All participants will wear lens A for 15 minutes (Period 1).

Group Type: EXPERIMENTAL

Lens A (omafilcon A)

Intervention Type: DEVICE

15 minutes of daily wear.

Lens B (comfilcon A)

All participants will wear lens B for 15 minutes (Period 2).

Group Type: EXPERIMENTAL

Lens B (comfilcon A)

Intervention Type: DEVICE

15 minutes of daily wear.

Interventions

Lens A (omafilcon A)

15 minutes of daily wear.

Intervention Type: DEVICE

Lens B (comfilcon A)

15 minutes of daily wear.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. They are aged 35 years or over and have capacity to volunteer.

2. They understand their rights as a subject and are willing to sign a Statement of Informed Consent.

3. They are willing and able to follow the protocol.

4. They agree not to participate in other clinical research for the duration of this study.

5. They are currently wearing soft contact lenses or have done so within the past 12 months.

6. They have a spherical prescription between +10.00 and -10.00DS inclusive, (based on the ocular refraction).

7. They have astigmatism of between -0.75 and -5.75DC (based on the ocular refraction) in each eye.

8. They have a reading addition component to their spectacle refraction of between +0.75 and +2.50DS.

9. They can be satisfactorily fitted with the study lenses.

10. They own a wearable pair of spectacles.

Exclusion Criteria

1. They have an ocular disorder which would normally contraindicate contact lens wear.

2. They have a systemic disorder which would normally contra-indicate contact lens wear.

3. They are using any topical medications such as eye drops or ointment.

4. They have had cataract surgery.

5. They have had corneal refractive surgery.

6. They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.

7. They have any ocular abnormality which would, in the opinion of the investigator, normally contraindicate contact lens wear.

8. They have eye or health conditions including immunosuppressive or infectious diseases which would, in the opinion of the investigator, contraindicate contact lens wear or pose a risk to study personnel; or a history of anaphylaxis or severe allergic reaction.

9. They have taken part in any other contact lens or care solution clinical trial or research, within two weeks prior to starting this study.

• Minimum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CooperVision, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Carole Maldonado-Codina, PhD,MCOptom

Role: PRINCIPAL_INVESTIGATOR

Eurolens Research

Locations

The University of Manchester

Manchester, , United Kingdom

Countries

United Kingdom

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

EX-MKTG-159

Identifier Type: -

Identifier Source: org_study_id